Delivering complete manufacturing visibility and control for combination and hybrid products without the overhead and complexity of traditional pharmaceutical systems
Camstar Medical Device Suite is the most widely adopted manufacturing execution system (MES) in the med tech industry. In addition to its well-known discrete processing capabilities, its batch processing features are easy-to-use and enable specific functionality for simple weighing and dispensing environments where individual batch orders are processed.
Designed specifically for medical device manufacturers with discrete or combination batch and discrete processes, Camstar Medical Device Suite with Batch Processing creates and maintains a complete electronic batch record (eBR) and electronic device history record (eDHR) as one fully traceable as-built record.
As a result, manufacturers can accelerate innovation, reduce cost, and achieve the highest quality products while making compliance a by-product of excellent manufacturing processes. The application enables them to build quality into the manufacturing process instead of testing quality coming out of the process at every step, from raw materials to finished goods with a complete, self-auditing eBR/eDHR.
For manufacturers of combination and hybrid products, specific functionality for their batch processes enable:
- Enforcement the correct operator, machine, materials/recipe, processes and measurements at every step
- Automatic download of material lists from enterprise resource planning (ERP) system
- Step-by-step operator instructions for weighing, dispensing and formulation
- Scale readings in real time and enforced target, minimum and maximum quantities
- Assured use of only qualified, available and calibrated scales
- Automatic forward and backward track-and-trace of weigh and dispense batch materials, and their consumption into discrete product manufacturing and final finished goods
A Single Source of Truth for Combination and Diagnostic Products
Combination products continue to blur the lines of separation between drugs, devices, and/or biological products. To learn more about batch in the med tech industry read A Single Source of Truth for Combination and Diagnostic Products by David R. Somers, Senior Industry Analyst, at Axendia